Events

Recall of CELLSEARCH CIRCULATING TUMOR CELL KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    36844
  • Event Risk Class
    II
  • Event Initiated Date
    2015-05-19
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Janssen diagnostics llc has received reports from customers about the intermittent occurrence of small bead-like structures or "artifacts" appearing in the image gallery for both control cells and patient samples of some cellsearch circulating tumor cell kits. the appearance of individual artifacts is not unusual. however review of the data has demonstrated an increase of artifacts appearing in the image gallery as unassigned events. artifacts are distinguishable from circulating tumor cells (ctcs) as they do not meet the criteria of a ctc. therefore they are not likely to be counted as ctcs when reviewing in the image gallery. however when testing patient samples there is a low probability that this type of artifact could potentially obscure the presence of ctcs.

Device

CELLSEARCH CIRCULATING TUMOR CELL KIT
  • Model / Serial
    Model Catalog: 7900001 (Lot serial: 0094B); Model Catalog: 7900001 (Lot serial: 0074B)
  • Product Description
    CELLSEARCH CIRCULATING TUMOR CELL KIT
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS